Regulatory Framework

Question 1

Which organisation provides the framework for national radiation regulations?

Answer 1

International Commission on Radiation Protection (ICRP).

Question 2

Which two historical events focussed minds in terms of radiation safety.

Answer 2

• Hiroshima atomic bomb.
• Fukishima Daiichi nuclear power plant.

Question 3

What are the ICRPs three concepts radiation protection? What strategies are used to employ these concepts?

Answer 3

• Justification (i.e. do we have to use radiation at all?).
• Optimisation (i.e. are we using the lowest dose?).
• Limitation (are we within dose limits?).

Strategies used to employ these concepts include:
- Consideration of routine and emergency exposures.
- Risk assessment.
- Local rules.
- Monitoring.
- Audit.
- Emergency plans.
- Dose constraints for all groups exposed or potentially exposed.

Question 4

Which radiation risk model does the ICRP adhere to?

Answer 4

Supports the use of the linear no threshold model i.e. risk of cancer induction increases linearly with radiation dose. This is proven with data at increased radiation doses and is inferred by extrapolation of this data to lower doses. ICRP recommends an overall risk of fatal cancer coefficient as ~ 5%/Sv.

Question 5

What does UNSCEAR stand for?

Answer 5

United Nations Scientific Committee on Effects of Atomic Radiation.

Question 6

What work does the International Commission on Radiation Units and Measurement (ICRU) focus on?

Answer 6

Quantities and units for radiation and radioactivity and procedures for measurement.

Question 7

What is the ICRP absorbed dose equation?

Answer 7

D = dE/dm where D is absorbed dose, dE is the mean energy imparted by ionising radiation and dm is the mass of matter to which the energy is imparted. Units are in J/Kg or Gy.

Question 8

Alongside ICRP, what is another international body covering the safe use of radiation?

Answer 8

International Atomic Energy Agency (IAEA). They focus on International cooperation and safe and sustainable uses for all radiation sources. They publish an international basic safety standard based on ICRP recommendations. They also produce technical publications and training packages and are an international nuclear inspectorate.

Question 9

Which standards direct national legislation on radiation safety in England and what do these standards cover?

Answer 9

• European Basic Safety Standard.
• This lays down basic safety standards for protection against the dangers arising from exposure to ionising radiation. It covers workers, public and patients and is generally consistent with the principles of ICRP.

Question 10

Who enforces IRR17?

Answer 10

Health and Safety Executive (HSE).

Question 11

To what applications does IRR17 apply?

Answer 11

• Any work practice which results in exposure to ionising radiation (e.g. medical exposures).
• Any work in an atmosphere with certain specified levels of radon is also included.

Question 12

Who has duties under IRR17?

Answer 12

Employers, employees and others directly affected.

Question 13

What are the three levels of informing HSE of types of work with ionising radiation?

Answer 13

• Notification of certain work. This is the lowest level and includes radon and very low activity radioactive materials.
• Registration of certain practices. This is the mid-level and would include most diagnostic x-ray work and the transport of radioactive materials.
• Consent to carry out specific practices. This is the highest level and would include nuclear medicine, linac work and HASS sources. This potentially includes a visit from HSE before the work can take place.

Question 14

After informing the HSE of work with ionising radiation to be undertaken, what must be done prior to undertaking this work, as per IRR17?

Answer 14

A prior risk assessment that is suitable and sufficient. This will identify hazards and the nature and magnitude of the risks arising from those hazards.

Question 15

In general, what concepts are considered in IRR17 Regulation 9 Restriction of Exposure?

Answer 15

• The as low as reasonably practicable (ALARP) concept.
• The hierarchy of control measures (elimination/substitution of exposure, engineering controls, administrative and work practices, PPE).

Question 16

What are the employers duties with regards to personal protective equipment (PPE), as per IRR17?

Answer 16

• PPE should be fit for purpose.
• It should have adequate storage.
• It should be maintained, as per regulation 11 which also covers the maintenance of engineering controls.

Question 17

What are the dose limits set out in Regulation 12 of IRR17?

Answer 17

Employee 18+:
- Whole body 20 mSv.
- Lens of eye 20 mSv.
- Skin 500 mSv.
- Extremities 500 mSv.

Trainee < 18:
- Whole body 6 mSv.
- Lens of eye 15 mSv.
- Skin 150 mSv.
- Extremities 150 mSv.

Public:
- Whole body 1 mSv.
- Lens of eye 15 mSv.
- Skin 50 mSv.
- Extremities 50 mSv

Question 18

What is required in the case of any reasonably foreseeable accidents determined from a risk assessment, as per IRR17?

Answer 18

• Contingency plans.
• These should be recorded in the local rules.
• They should be disseminated to relevant employees.
• They should be rehearsed, where appropriate.

Question 19

Who advises an employer on relevant aspects of radiation protection and adherence to IRR17 for work with ionising radiation?

Answer 19

Radiation Protection Advisor (RPA).

Question 20

What is required as part of IRR17 to ensure all staff involved with work with ionising radiation are competent?

Answer 20

Information, instruction and training (repeated at regular intervals) on the following:
- The risks associated with radiation exposure (including the risk to the foetus for the exposure of pregnant staff).
- General radiation protection procedures.
- The importance of compliance with the regulations.
- Specific training for work within controlled areas.
- Specific training for work with HASS sources.

Question 21

What does IRR17 require if an employee works with radiation for two different employers?

Answer 21

• Cooperation between employers.
• Exchange information regarding the exposure levels of the employee.

Question 22

Why are some areas designated and what are the designation limits, as per IRR17?

Answer 22

• Controlled area: Potential for 6 mSv/year whole body, 15 mSv/year lens of eye, 150 mSv/year skin or extremities. Controlled areas require special procedures to be in place to restrict exposures..
• Supervised area: Potential for 1 mSv/year whole body dose. Supervised areas required on-going review to determine whether they should be designated as controlled areas.

Question 23

Which document is required by IRR17 to provide systems of work for controlled areas and supervised areas, where appropriate? Who ensures these are adhered to?

Answer 23

• Local rules provide the systems of work for a controlled area which restrict exposure to levels that are ALARP.
• The employer is responsible for ensuring local rules are observed. A Radiation Protection Supervisor (RPS) is employed to ensure adherence to the regulations with regards to the local rules.
• Local rules should be made available and disseminated to the relevant employees.

Question 24

What are the additional requirements for designated areas, as per IRR17?

Answer 24

• The designated area is described adequately in local rules.
• Has suitable and sufficient warning signage.
• Is physically demarcated.
• Access should be limited to classified workers or those who have been authorised access under suitable written arrangements (this would include the wearing of PPE).
• Special arrangements for outside workers (e.g. dose estimates).

Question 25

In which areas is environmental monitoring required, as per IRR17? What are the requirements for the monitoring?

Answer 25

• In all designated areas.
• Suitable and sufficient equipment should be used that is regularly maintained.
• Suitable records should be kept.

Question 26

When does a worker need to be classified? What additional measured are required for classified worker?

Answer 26

• A person should be classified if there is a likelihood they will receive 6 mSv/year whole body, 15 mSv/year lens of eye, 150 mSv/year skin or extremities.
• A classified worker needs to be certified to work with ionising radiation by an appointed doctor. They can not be a trainee < 18.

Question 27

What is covered in terms of dosimetry in IRR17?

Answer 27

• Personal dosimetry from an approved dosimetry service.
• Dose assessments.
• Estimated doses.
• Dosimetry for accidents.
• The keeping and maintaining of dosimetry records.
• Arrangements for outside workers (e.g. radiation passbooks).
• Dose estimations.

Question 28

What would happen in the case of an overexposure, as per IRR17?

Answer 28

• The appropriate authority (HSE), any other employers of the employee, the relevant doctor and the employee would need to be notified.
• An overexposure investigation would be required (circumstances, dose assessment etc.).
• Investigation report.
• Dose limitation for overexposed employees.

Question 29

Who is medical surveillance required for, as per IRR17?

Answer 29

• Classified persons or those who the employer intends to classify.
• Employees who have received an overexposure.
• Employees for whom a relevant doctor has made a certification.

Question 30

What aspects of radioactive materials are covered in IRR17? Where else are these covered?

Answer 30

• Sealed sources.
• Accounting for radioactive substances.
• Keeping and moving of radioactive substances.
• Notification of certain occurrences (e.g. loss or theft of radioactive materials).
• These aspects are also covered in the Environmental Permitting Regulations 2016 (EPR16).

Question 31

What are the general duties of the manufacturer, as per IRR17?

Answer 31

• Appropriate equipment design.
• Safety features.
• Critical examination (installer) and communication of this with the RPA.
• Provision of information to the employer regarding appropriate use, testing and maintenance.

Question 32

Who does IR(ME)R apply to?

Answer 32

• Patients.
• Carers and comforters.
• Asymptomatic individuals (e.g. as part of a screening program).
• Non-medical imaging (e.g. medical legal procedures).

Question 33

Who controls operational aspects of IR(ME)R licensing and who advises on this?

Answer 33

• Public Health England (PHE) covers operational aspects on behalf of licensing authorities.
• They are advised by the Administration of Radioactive Substances Advisory Committee (ARSAC).

Question 34

Who is required to hold a license, as per IR(ME)R?

Answer 34

• The employer requires a separate license at each installation where the administration of radioactive substances will take place.
• A license is required by a practitioner to administer radioactive substances for a specified purpose.

Question 35

What are the employer’s duties with regards to the establishment of general procedures, protocols and quality assurance programmes, as per IR(ME)R?

Answer 35

• A general set of employer’s procedures to provide a framework for practice.
• Must ensure operators and practitioners are adequately trained and undertaken continuing professional development.
• Written protocols for every type of standard radiological practice.
• Referral guidelines for medical exposure.
• Quality assurance programmes for these written procedures and protocols.
• Regular review and update of local diagnostic reference levels.
• Dose constraints for research protocols.
• Reviews of any consistent exceeding of diagnostic reference levels.
• Taking steps to identify pregnant or breastfeeding patients.

Question 36

What is the purpose of clinical audit, as per IR(ME)R?

Answer 36

An example of clinical audit might be the role of diagnostic x-ray imaging in a clinical pathway and its benefits in relation to the overall outcome. This can, therefore, result in optimisation of exposures.

Question 37

What are the duties of the employer with regards to accidental and unintended exposures?

Answer 37

• Ensure professionals involved with the care of the patient are informed of the exposure to ensure appropriate care can be provided in the future.
• Systems for recording analyses of such events should be in place. Near misses and errors should be included.
• To conduct immediate preliminary investigations of such events (identify what happened, the cause, remedial actions and dose estimates).
• Notification to the relevant authority (CQC) of significant accidental or unintended exposures.

Question 38

What are the duties of the relevant enforcing authority with regards to accidental and unintended exposures?

Answer 38

They should put in place mechanisms to provide information on significant events to enable learning from experience and the implementation preventative measures to minimise the probability of similar events occurring.

Question 39

What are the duties of the practitioner, operator and referrer as per IR(ME)R?

Answer 39

• Compliance with employer’s procedures.
• Practitioner responsible for the justification and authorisation of an exposure.
• Operator responsible for practical aspects of an exposure.
• Operator responsible for authorisation of a procedure in certain situations.
• The referrer is responsible for supplying the practitioner with sufficient medical data for the justification process.

Question 40

What must be considered when justifying a procedure, as per IR(ME)R?

Answer 40

• Licensing of practitioner and employer.
• Information provided by the referrer.
• Net benefit of the exposure (e.g. diagnostic/therapeutic benefits vs health detriment).
• Approval by an ethics committee for research exposures.
• Potential for pregnancy or breastfeeding.
• Advice from relevant bodies and scientific societies.
• Exposure to comforters and carers.
• Exposure of asymptomatic individuals.
• The urgency of an exposure.

Question 41

How is optimisation achieved, as per IR(ME)R?

Answer 41

• The practitioner and operator must ensure doses are kept ALARP.
• The operator must select equipment and methods accounting for the above bearing in mind quality assurance, assessment and evaluation of patient dose and adherence to diagnostic reference levels.
• Dose constraints for research exposures.
• Clinical evaluation of the outcome of each exposure.

Question 42

What is the employer’s responsibility in contributing to estimates of population dose?

Answer 42

Must ensure dose estimates are collected from procedures (alongside other patient details) and provide these to the secretary of state, upon request.

Question 43

Who is responsible for providing expert advice and what do they advise on, as per IR(ME)R?

Answer 43

The employer must appoint a suitable Medical Physics Expert (MPE). They should provide advice on:
- Optimisation.
- Dosimetry and QA.
- Physical measurements of dose delivered.
- Equipment.
- Acceptance testing.
- Accidental and unintended exposures.
- Training of practitioners.
- Compliance with regulations.

Question 44

What are the general duties of the employer with regards to equipment, as per IR(ME)R?

Answer 44

• Implementation of QA programme with testing before first use, at regular intervals and after maintenance or modification.
• Keep and inventory of equipment.
• Ensure equipment installed after 6th February 2018 has a device for assessing patient dose (e.g. DAP meter) and has the ability to transfer information to the record of a person’s exposure.

Question 45

What are the training requirements for IR(ME)R duty holders?

Answer 45

• Practitioners and operators must be adequately trained before carrying out any exposure.
• The employer must keep an up to date record of all relevant training.

Question 46

Other than IRR17 and IR(ME)R, name three other regulations relevant to uses of radiation in healthcare and their enforcing authorities.

Answer 46

• Environmental Permitting Regulations (Environment Agency). Covers security and disposal of RAM.
• Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations (Office for Nuclear Regulation). Covers transport of RAM and other dangerous goods.
• Radiation Emergency Preparedness, Resilience and Response Regulations (Health and Safety Executive). Covers emergency radiation accident planning.